Using spirometry to manage IgG therapy in patients with Common Variable Immunodeficiency and airway disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the role of spirometry in managing immunoglobulin therapy for patients with Common Variable Immunodeficiency (CVID) who exhibit mild to moderate airway obstruction. The study will enroll 22 participants currently receiving stable immunoglobulin replacement therapy and assess their lung function using spirometry. Half of the participants will continue their current treatment while the other half will receive an increased dose of therapy over six months to evaluate improvements in lung function. The goal is to determine if higher doses of immunoglobulin can enhance lung function in patients with specific spirometry results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who meet criteria for common variable immune deficiency (CVID) who are on stable IGRT for at least 3 months and who have an FEF25-75% between 50% and 80% of predicted.
2. Patients who are already on Hizentra will be preferred.

Exclusion Criteria:

1. Age \<21 or cannot perform spirometry.
2. Smokers with 20 pack years or more, and active smokers will not be included among the study subjects, but will be considered separately as an ancillary study.
3. Patients with specific antigen-specific antibody deficiencies or X-linked agammaglobulinemia on IGRT will not be included among the 20 study subjects, but will be considered separately in ancillary studies.
4. Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.

Where it's running

• Community Health 20
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Harry Schroeder, MD/PhD — University of Alabama at Birmingham
• Study coordinator: Leigh Powell
• Email: lcpowell@uabmc.edu
• Phone: 2053319159

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.